Duns Number:057827420
Device Description: Neonatal High Efficiency Leukocyte Reduction Filter for Red Blood cells with Attached 175 Neonatal High Efficiency Leukocyte Reduction Filter for Red Blood cells with Attached 175 mL PVC Aliquot Bag with Needleless Injection Port
Catalog Number
-
Brand Name
Haemonetics
Version/Model Number
NEO1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BK850026,BK850026
Product Code
CAK
Product Code Name
Microfilter, blood transfusion
Public Device Record Key
c072f8b1-8c1d-4870-a88d-076ea140ae20
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 15, 2016
Package DI Number
30887691003876
Quantity per Package
20
Contains DI Package
10887691003872
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |
| U | Unclassified | 2 |